Breast Cancer Clinical Trial
— ONCODAGEOfficial title:
Validation of a Screening Tool in Geriatric Oncology
Verified date | March 2021 |
Source | Institut Bergonié |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer. PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.
Status | Completed |
Enrollment | 1674 |
Est. completion date | March 8, 2015 |
Est. primary completion date | March 8, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years to 120 Years |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed cancer including the following types: - Colon - Rectal - Lung - Squamous cell carcinoma of the head and neck - Breast - Prostate - Non-Hodgkin lymphoma - Planning to undergo first-time treatment comprising medicine, surgery, or radiotherapy PATIENT CHARACTERISTICS: - No persons deprived of liberty or under guardianship - No psychological, familial, social, or geographical reasons that would make monitoring clinically impossible PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonie | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
Institut Bergonié | National Cancer Institute, France |
France,
Bellera CA, Artaud F, Rainfray M, Soubeyran PL, Mathoulin-Pélissier S. Modeling individual and relative accuracy of screening tools in geriatric oncology. Ann Oncol. 2017 May 1;28(5):1152-1157. doi: 10.1093/annonc/mdx068. — View Citation
Soubeyran P, Bellera C, Goyard J, Heitz D, Curé H, Rousselot H, Albrand G, Servent V, Jean OS, van Praagh I, Kurtz JE, Périn S, Verhaeghe JL, Terret C, Desauw C, Girre V, Mertens C, Mathoulin-Pélissier S, Rainfray M. Screening for vulnerability in older c — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of the G8 Questionnaire | Sensitivity of the G8 questionnaire measured as Percentage of Participants with a Positive G8 among patients with a positive MGA. The G8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14. Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale. |
at inclusion (at completion of the G8 questionnaire) | |
Secondary | Specificity of the G8 Questionnaire | Specificity of the G8 questionnaire measured as percentage of participants with a negative G8 test among patients with a negative MGA.The G8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14. Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale. |
at inclusion (at completion of the G8 questionnaire) | |
Secondary | Sensitivity of the VES-13 Questionnaire | Sensitivity of the VES-13 questionnaire measured as percentage of participants with a positive VES-13 test among patients with a positive MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment. Multidimensional geriatric assessment (MGA): see measure description for primary outcome. |
at inclusion | |
Secondary | Specificity of the VES-13 Questionnaire | Specificity of the VES-13 questionnaire measure as the percentage of participants with a negative VES-13 test among patients with a negative MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment. Multidimensional geriatric assessment (MGA): see measure description for primary outcome. |
at inclusion (at completion of the G8 questionnaire) | |
Secondary | Reproducibility of the G8 Questionnaire | Reproducibility of G8 was assessed by comparing the score on the actual G8 with the scores extracted from the corresponding seven questions of MNA completed during the MGA for all patients. The G8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14. | at inclusion (at completion of the G8 questionnaire) | |
Secondary | Reproducibility of the VES-13 Questionnaire | Reproducibility of VES-13 was assessed based on a subgroup of patients included in three pre-identified centers who completed the questionnaire on two occasions. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment. | at inclusion (at completion of the G8 questionnaire) |
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